Methods and apparatus for sampling and analyzing body fluid

ABSTRACT

A sampling device for sampling body fluid includes a lancet for making an incision, a capillary tube for drawing-up body fluid from the incision, and a test strip affixed to an upper end of the capillary tube for receiving the fluid. An absorbent pad can be disposed between the test strip and capillary tube for spreading-out the fluid being transferred to the test strip. An on-site analyzer such as an optical analyzer and/or an electrochemical analyzer can be mounted in the device for analyzing the fluid. Alternatively, a test strip can be slid through a slot formed in the bottom end of the device so that by passing the device against the skin after an incision has been formed, the test strip will directly contact body fluid emanating from the incision.

REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation of application Ser. No.09/887,574 filed Jun. 21, 2001, which is a continuation of applicationSer. No. 09/552,243 filed Apr. 19, 2000, now U.S. Pat. No. 6,352,514,which is a continuation of application Ser. No. 09/298,386 filed Apr.23, 1999, now U.S. Pat. No. 6,099,484, which is a continuation ofapplication Ser. No. 08/858,042 filed May 16, 1997, now U.S. Pat. No.5,951,492, which claims benefit of provisional Application Serial Nos.60/017,133 filed May 19, 1996; 60/019,918 filed Jun. 14, 1996;60/023,658 filed Aug. 1, 1996; 60/025,340 filed Sep. 3, 1996; 60/064,856filed Sep. 17, 1996; 60/092,121 filed Sep. 16, 1996 and 60/044,406 filedOct. 8, 1996, the disclosures of which are incorporated herein byreference. The present invention is related to inventions disclosed inthe following concurrently filed, commonly assigned U.S. Applications:Ser. No. 08/857,680, now U.S. Pat. No. 5,879,311 entitled “Body FluidSampling Device and Methods of Use”; Ser. No. 08/858,045; now U.S. Pat.No., 5,857,983 entitled “Disposable Element for Use in a Body FluidSampling Device”; Ser. No. 08/858,043 entitled “Methods and Apparatusfor Expressing Body Fluid From an Incision”; and Ser. No. 08/975,978entitled “Body Fluid Sampling Device”. The disclosures of thoseapplications are incorporated herein by reference.

FIELD OF THE INVENTION

[0002] The present invention relates to lancing devices and methods forobtaining samples of blood and other fluids from the body for analysisor processing.

BACKGROUND OF THE INVENTION

[0003] Many medical procedures in use today require a relatively smallsample of blood, in the range of 5-50 μL. It is more cost effective andless traumatic to the patient to obtain such a sample by lancing orpiercing the skin at a selected location, such as the finger, to enablethe collection of 1 or 2 drops of blood, than by using a phlebotomist todraw a tube of venous blood. With the advent of home use tests such asself monitoring of blood glucose, there is a requirement for a simpleprocedure which can be performed in any setting by a person needing totest.

[0004] Lancets in conventional use generally have a rigid body and asterile needle which protrudes from one end. The lancet may be used topierce the skin, thereby enabling the collection of a blood sample fromthe opening created. The blood is transferred to a test device orcollection device. Blood is most commonly taken from the fingertips,where the supply is generally excellent. However, the nerve density inthis region causes significant pain in many patients. Sampling ofalternate sites, such as earlobes and limbs, is sometimes practiced toaccess sites which are less sensitive. These sites are also less likelyto provide excellent blood samples and make blood transfer directly totest devices difficult.

[0005] Repeated lancing in limited surface areas (such as fingertips)results in callous formation. This leads to increased difficulty indrawing blood and increased pain.

[0006] To reduce the anxiety of piercing the skin and the associatedpain, many spring loaded devices have been developed. The following twopatents are representative of the devices which were developed in the1980's for use with home diagnostic test products.

[0007] U.S. Pat. No. 4,503,856, Cornell et al., describes a springloaded lancet injector. The reusable device interfaces with a disposablelancet. The lancet holder may be latched in a retracted position. Whenthe user contacts a release, a spring causes the lancet to pierce theskin at high speed and then retract. The speed is important to reducethe pain associated with the puncture.

[0008] Levin et al. U.S. Pat. No. 4,517,978 describes a blood samplinginstrument. This device, which is also spring loaded, uses a standarddisposable lancet. The design enables easy and accurate positioningagainst a fingertip so the impact site can be readily determined. Afterthe lancet pierces the skin, a bounce back spring retracts the lancet toa safe position within the device.

[0009] In institutional settings, it is often desirable to collect thesample from the patient and then introduce the sample to a test devicein a controlled fashion. Some blood glucose monitoring systems, forexample, require that the blood sample be applied to a test device whichis in contact with a test instrument. In such situations, bringing thefinger of a patient directly to the test device poses some risk ofcontamination from blood of a previous patient. With such systems,particularly in hospital settings, it is common to lance a patient,collect a sample in a micropipette via capillary action and then deliverthe sample from the pipette to the test device.

[0010] Haynes U.S. Pat. No. 4,920,977 describes a blood collectionassembly with lancet and microcollection tube. This device incorporatesa lancet and collection container in a single device. The lancing andcollection are two separate activities, but the device is a convenientsingle disposable unit for situations when sample collection prior touse is desirable. Similar devices are disclosed in Sarrine U.S. Pat. No.4,360,016, and O'Brien U.S. Pat. No. 4,924,879.

[0011] Jordan et al. U.S. Pat. Nos. 4,850,973 and 4,858,607, disclose acombination device which may be alternatively used as a syringe-typeinjection device and a lancing device with disposable solid needlelancet, depending on configuration.

[0012] Lange et al. U.S. Pat. No. 5,318,584 describes a blood lancetdevice for withdrawing blood for diagnostic purposes. This inventionuses a rotary/sliding transmission system to reduce the pain of lancing.The puncture depth is easily and precisely adjustable by the user.

[0013] Suzuki et al. U.S. Pat. No. 5,368,047, Dombrowski U.S. Pat. No.4,653,513 and Ishibashi et al. U.S. Pat. No. 5,320,607 each describesuction-type blood samplers. These devices develop suction between thelancing site and the end of the device when the lancet holding mechanismwithdraws after piercing the skin. A flexible gasket around the end ofthe device helps seal the end around the puncture site until adequatesample is drawn from the puncture site or the user pulls back on thedevice.

[0014] Garcia et al. U.S. Pat. No. 4,637,403 discloses a combinationlancing and blood collection device which uses a capillary passage toconduct body fluid to a separate test strip in the form of a microporousmembrane. It is necessary to achieve a precise positioning of the upperend of the capillary passage with respect to the membrane in order toensure that body fluid from the passage is transferred to the membrane.If an appreciable gap exists therebetween, no transfer may occur.

[0015] Also, the diameter of the capillary passage is relatively small,so the width of a sample transferred to the membrane may be too small tobe measured by on-site measuring devices such as an optical measuringsystem or an electrochemical meter.

[0016] It is difficult for a user to determine whether a sufficientlylarge drop of body fluid has been developed at the incision forproviding a large enough sample.

[0017] International Publication Number WO 95/10223, Erickson et al.,describes a means of collecting and measuring body fluids. This systemuses a disposable lancing and suction device with a spacer member whichcompresses the skin around the lance/needle.

[0018] Single use devices have also been developed for single use tests,i.e. home cholesterol testing, and for institutional use to eliminatecross-patient contamination multi-patient use. Crossman et al. U.S. Pat.No. 4,869,249, and Swierczek U.S. Pat. No. 5,402,798, also disclosedisposable, single use lancing devices.

[0019] The disclosures of the above patents are incorporated herein byreference.

[0020] An object of the present invention is to ensure that asufficiently large drop of body fluid is developed at an incision, andthat the body fluid reaches a test strip.

[0021] Another object is to ensure that the sample applied to the teststrip creates a measurement area that is sufficiently wide to beproperly analyzed.

[0022] An additional object is to provide a novel electrochemicalanalyzing system for analyzing a sample in the lancing device.

[0023] A further object is to enable a sample of body fluid to beapplied to a test strip which is mounted in a lancing device.

[0024] Another object of this invention is to provide a method which canresult in a sample of either blood or interstitial fluid, depending onthe sample site and the penetration depth utilized. While there are nocommercially available devices utilizing interstitial fluid (ISF) atthis time, there are active efforts to establish the correlation ofanalytes, such as glucose, in ISF compared to whole blood. If ISF couldbe readily obtained and correlation is established, ISF may bepreferable as a sample since there is no interference of red blood cellsor hematocrit adjustment required.

[0025] Another object of this invention is to provide a method which candraw a small but adjustable sample, i.e. 3 μL for one test device and 8μL for another test device, as appropriate.

[0026] Another object of this invention is to provide a method by whichthe drawn sample is collected and may be easily presented to a testingdevice, regardless of the location of the sample site on the body. Thisapproach helps with infection control in that multiple patients are notbrought in contact with a single test instrument; only the samplingdevice with a disposable patient-contact portion is brought to the testinstrument. Alternatively, the disposable portion of a test device maybe physically coupled with the sampler so the sample can be broughtdirectly into the test device during sampling. The test device may thenbe read in a test instrument if appropriate or the testing system can beintegrated into the sampler and the test device can provide directresults displayed for the patient.

[0027] A further object is to provide an on-site test strip with arelatively wide sample which can be analyzed by on-site analyzers suchas optical and electrochemical analyzers.

[0028] It is a further object of the invention to provide a device forminimally invasive sampling comprising a reusable sampler and disposablelancet and sample collection device.

SUMMARY OF THE INVENTION

[0029] One aspect of the present invention relates to a sampling devicefor sampling body fluid. The device includes a housing and a lancetcarrier mounted in the housing for supporting a disposable lancet. Thedevice also includes a mechanism for displacing the lancet carriertoward a lower end of the housing for forming an incision in a user. Abody fluid sampling member is mounted in the housing for conducting bodyfluid from the incision. That sampling member comprises a capillarymember, and a test strip. The capillary member includes an elongatedstem having a capillary passage extending longitudinally therethroughfor conducting body fluid upwardly by capillary action. The test stripis affixed to the capillary member at an upper end thereof and incommunication with the capillary passage for receiving a sample of bodyfluid.

[0030] Preferably, the test strip comprises a microporous membrane, andan absorbent pad is preferably disposed between the test strip and theupper end of the capillary passage for wicking body fluid from thepassage to the test strip.

[0031] The present invention also relates to the capillary member perse.

[0032] Another embodiment of the sampling device includes a housing, alancet carrier mounted in the housing for supporting a disposablelancet, a mechanism for displacing the lancet carrier toward a lower endof the housing for forming an incision in a user, and a strip-holdingmechanism mounted at a lower end of the housing for supporting a teststrip across the lower end of the housing to enable the test strip topick up body fluid from the incision.

[0033] The strip holding mechanism preferably comprises a sleevedisposed in surrounding relationship to the lancet carrier and includesradially aligned slots for receiving a test strip.

[0034] Preferably, the sleeve constitutes a first sleeve, and theholding mechanism further includes a second sleeve surrounding the firstsleeve and including slots that are radially aligned with the slots ofthe first sleeve. The second sleeve is slidable longitudinally relativeto both the housing and the first sleeve and is spring biaseddownwardly. The slots which are formed in the second sleeve areelongated in a direction parallel to a longitudinal axis of the housingto enable the second sleeve to move longitudinally relative to a teststrip mounted in the first sleeve.

[0035] The present invention also relates to a method of sampling bodyfluid which comprises the steps of positioning a lower end of a samplingdevice against a skin surface, and displacing a lancet carrier towardthe lower end of the sampling device to form an incision through theskin. A test strip is positioned in the sampling device to extend acrossthe lower end thereof. The sampling device is moved toward the incisionto bring the test strip into contact with body fluid emerging from theincision. The test strip is preferably positioned in the sampling deviceprior to the displacement of the lancet toward the lower end of thesampling device, whereby the lancet pierces the test strip.

[0036] Another aspect of the invention involves the provision of adrop-detecting mechanism on the lancing device adjacent a lower endthereof for detecting a drop of body fluid on the user's skin. Themechanism can be in the form of electrodes which contact the drop, or anoptical system including a light emitter and a light sensor. Thedrop-detecting mechanism automatically determines whether a drop ofsufficient size has been developed at the incision for providing aproper sample.

BRIEF DESCRIPTION OF THE DRAWINGS

[0037] The objects and advantages of the invention will become apparentfrom the following detailed description of preferred embodiments thereofin connection with the accompanying drawings in which like numeralsdesignate like elements and in which:

[0038]FIG. 1 is a side elevational view, partially broken away, of ablood sampling device according to the present invention, with acapillary tube thereof disposed in a retracted state;

[0039]FIG. 2 is a view similar to FIG. 1 after an incision has beenmade, and the capillary tube has been extended;

[0040]FIG. 3 is a longitudinal sectional view through one embodiment ofthe capillary tube according to the present invention;

[0041]FIG. 4 is a longitudinal sectional view taken through anotherembodiment of a capillary tube according to the present invention;

[0042]FIG. 5 is view similar to FIG. 2 of a sampling device having analternative form of analyzing instrument;

[0043]FIG. 6 is a fragmentary view of a lower end of a lancing device,depicting a drop-detecting mechanism according to the present invention;

[0044]FIG. 7 is a side elevational view, partially broken away ofanother embodiment of the sampling device, with a test strip mounted ata lower end thereof; and

[0045]FIG. 8 is a fragmentary view of the device depicted in FIG. 7 in asampling-taking state.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION

[0046] Depicted in FIGS. 1 and 2 is a lancing device 10 for making anincision through a skin surface S, wherein a disposable lancet 12(hereinafter referred to as a “disposable”) which carries a skin-lancingmember in the form of a needle 14 can be displaced toward the skinsurface by a cocked spring and then rapidly retracted by another spring.Devices of this general type are known, and one preferred device isdisclosed in commonly assigned, concurrently filed U.S. application Ser.No. 08/857,680, now U.S. Pat. No. 5,879,311, the disclosure of which isincorporated herein by reference.

[0047] As disclosed in that application, the disposable 12 includes abody 16 which carries not only the needle 14, but also a capillary tube18. The capillary tube is mounted by friction fit between holdingelements 15 that are integral with the body 16 and is downwardlyslidable relative to the body 16 in response to manual downwarddisplacement of a pusher 20 which possesses an exposed actuator knob 22.

[0048] The disposable 12 is situated telescopingly within a cylindricalstimulator sleeve 24 which is slidable longitudinally relative to ahousing 26 of the device. The sleeve 24 is biased downwardly, orforwardly, by a spring 28. Following the cutting of an incision I in theskin and the retraction of the lancet, the housing can be repeatedlypushed downwardly against the skin as required to express theappropriate sample from the incision, whereupon the sleeve depresses aring of body tissue in surrounding relationship to the incision, causingthe incision to bulge while spreading apart the sides of the incision.Consequently, a drop D of body fluid such as blood or interstitial fluidis formed at the open end of the incision, even if the incision I hasbeen made in a region of the body where the supply of body fluid isrelatively low as compared to, say, the fingertip region.

[0049] Once the drop D has been created, the pusher 22 is displaced topush the capillary tube downwardly to a state where the lower end of thecapillary tube can be dipped into the body fluid drop to obtain asample. The pusher is then released for return to an upper position by areturn spring (not shown). As disclosed in the aforementionedapplication, the fluid can then be transferred from the capillary tubeto a test strip, thereby making the overall sampling procedure moreconvenient.

[0050] In accordance with the present invention, the sampling procedureis made even more convenient by eliminating the need to transfer thebody fluid from the capillary tube.

[0051] In a first embodiment, the capillary tube carries its own teststrip. Depicted in FIG. 3 is a test strip 30 in the form of amicroporous membrane (preferably of the type disclosed in commonlyassigned U.S. application Ser. No. 08/628,489, filed Apr. 5, 1996, thedisclosure of which is incorporated by reference herein).

[0052] The membrane 30 is bonded, e.g. by a suitable adhesive, to anenlarged head or flange portion 32 of the capillary tube 18 whichprojects laterally with respect to a stem portion 34 of the capillarytube. The head 32, when viewed from the top, can be of any shape, suchas circular or rectangular (e.g., square). A capillary passage 36extends longitudinally through the stem 34 and head 32 to conduct bodyfluid into contact with the membrane by capillary action.

[0053] As is known in the art of capillary tubes, the amount of bodyfluid which is drawn up by capillary action can be regulated by asuitable selection of diameter and length of the passage 36, therebyensuring that a proper dosing of the membrane is achieved.

[0054] Fluid analyzing instruments can be mounted within the housing.For example, a conventional optical analyzing mechanism can be providedwhich includes a light source 40 and a light sensor 42 such as aphototransistor, which are electrically connected to a conventionalelectronics unit 44 for monitoring a color change of the sample as thesample reacts with chemicals in the test strip. The electronics unit 44displays the results on a display panel 90. In that way, for example,the glucose level in blood can be measured. The unit 44 is electricallyconnected to a battery 45 that is mounted in the housing.

[0055] In lieu of an optical analyzing mechanism, an electrochemicalmechanism can be provided in a device 10′ (FIG. 5), the mechanismincluding an electrochemical meter 50 which measures glucose levels. Themeter 50 is electrically connected to a battery 51 mounted in thehousing. The test strip 52 in this case would be provided with a printedelectrical circuit, and the pusher 24′ would possess electrical leads 54positioned so as to contact respective portions of the printed circuitelectrical paths on the test strip when the pusher 24′ is in its lowerposition (after having pushed the capillary tube down). Thus, the sampleconducted to the test strip 52 by the capillary tube will contact theelectrical circuit for conducting a current therebetween when the leads54 are brought into contact with the circuit. The leads are connected tothe meter 50 which measures the current. Since the level of current isproportional to the glucose concentration, the meter 50 is able tomeasure that concentration.

[0056] When the disposable 12 is discarded after a testing operation,the capillary tube 18 and test strip 30 will be discarded therewith. Afresh disposable is then installed to present a new needle 14, capillarytube 18 and test strip 30. Thus, the user never has to touch orotherwise maneuver a test strip separately from the capillary tube,since the test strip is attached thereto.

[0057] An alternate embodiment of a capillary tube 18′ is depicted inFIG. 4 wherein an absorbent pad 60 is disposed between the test strip 30and the head 32′ of the capillary tube 18′. That is, the absorbent pad,which can be formed of cellulose or suitable membrane, is bonded to thecapillary tube 18′, and the membrane 30 is bonded to the absorbent pad,or to a ring 62 which extends around a circumferential outer edge faceof the absorbent pad 60. That ring, together with the flange 32, forms acover which covers portions of the absorbent pad not covered by themembrane 30 to prevent the escape of the body fluid sample. When thecapillary tube draws-up body fluid by capillary action, that fluid iswicked by the absorbent pad and supplied to the test strip 30. Anadvantage of the capillary tube 18′ is that the absorbent pad willspread-out the fluid so that a wider sample is applied to the test stripto facilitate analysis.

[0058] A backpressure may occur which opposes a flow of body fluidthrough the absorbent pad 60. To deal with that potential problem, thehead 32′ is provided with air vent openings 64 to relieve thebackpressure and facilitate the flow of fluid through the pad 60. Theair vents are spaced laterally from the passage 36 and communicate withthe pad. The diameter of the vent openings is smaller than that of thecapillary tube and small enough to prevent the passage of body fluidtherethrough.

[0059] Instead of being bonded directly to the absorbent pad 60, themembrane 30 could be bonded to the ring 62. In that case, the absorbentpad 60 could be bonded to the membrane, or to the cover, or to thecapillary tube.

[0060] In any event it will be appreciated that the test strip isaffixed, either directly or indirectly, to the capillary tube toconstitute an integral part thereof.

[0061] One problem faced by a user is being able to determine whether adrop of body fluid expressed from an incision is of sufficient size toprovide a proper sample. That determination can be made automatically bya sampling device 10″ in accordance with an embodiment of the inventiondepicted in FIG. 6 wherein a drop sensing mechanism 65 is mounted on aninner sleeve 66. The drop sensing mechanism comprises a pair ofdiametrically opposed elements 67, 68. In one embodiment, those elementscomprise a pair of electrodes connected by wires 69 to the battery 45 or51 and positioned such that when the outer sleeve 24 is retracted inresponse to a pressing down of the housing, the electrodes will makecontact with the drop of body fluid only if the drop is of sufficientheight to provide an adequate sample. If such contact is made, the dropwill close a circuit, enabling a sensor to determine that the drop is ofample size. An indicator, such as a lamp 71 can be energized to advisethe user.

[0062] Alternatively, the elements 67, 68 of the mechanism 65 couldcomprise a light emitter and light receiver, respectively. When the dropof body fluid is of sufficient height, it will block the transmission oflight to the receiver, thus indicating that the drop is of sufficientsize, and triggering the energization of the lamp 71.

[0063] The drop-detecting mechanism 65 can be used with either of theembodiments disclosed in connection with FIGS. 1-2 and 5. However, it isnot necessary that the incision be formed by a lancet. Other incisionforming devices could be used such as a laser beam or pressurized fluid.That is, known pneumatic or hydraulic injectors of the type which injectpressurized gas or liquid against the skin could be used. Such autoinjectors are sold by Becton-Dickinson, for example, to inject insulin.By eliminating the insulin and merely injecting the gas (e.g., air ornitrogen) or liquid (e.g., water) at pressures above 30 psi, an incisioncould be formed in the skin for taking samples of body fluid.Advantageously, small particles could be mixed with the gas to promotethe tissue-cutting action. The particles could comprise carbon particlesof from 1 micron to 0.010 inches in diameter.

[0064] Another embodiment of a sampling device 10″ according to theinvention is depicted in FIGS. 7 and 8. In that embodiment, thestimulator sleeve 24 is slidable longitudinally relative to housing 26″and is provided with a through-slot 70, and an inner sleeve 72 (whichsupports the disposable), is provided with a through-slot 74 that isaligned with the through-slot 70. Those aligned through-slots 70, 74 areadapted to receive a test strip 30″ which, if desired, includes anabsorbent pad 60″. The test strip 30″, which may comprise a porousmembrane 30A″ and an absorbent pad 60″ attached thereto, is manuallyinserted through the slots 70, 74 by the user.

[0065] When a lancing procedure is performed, the lancet pierces thetest strip 30″ en route to the skin surface. Then, as the housing isrepeatedly pushed down to pump body fluid to the open end of theincision as described earlier, the stimulator sleeve 24″ will berepeatedly retracted, and simultaneously the inner sleeve 72, along withthe test strip 30″, will approach and contact the drop of body fluid asshown in FIG. 8, whereby a sample of the fluid is collected on the teststrip.

[0066] Then, the user removes the test strip for testing at an off-siteanalyzer.

[0067] It will be appreciated that the present invention enables a teststrip to be easily installed into and removed from a lancing device,thereby minimizing any risk of contamination of the sample. In theexamples according to FIGS. 1-5 the test strip is installed along withthe disposable lancet, thereby being automatically positioned in properrelationship to receive a sample and to permit the sample to be analyzedby an on-site analyzing instrument. If desired, however, the analysiscould be performed by an off-site instrument by removing the disposablefrom the device and taking it to the off-site instrument. In the exampleof FIGS. 7-8, the test strip is easily installed/removed by being passedthrough readily accessible slots.

[0068] Although the present invention has been described in connectionwith preferred embodiments thereof, it will be appreciated by thoseskilled in the art that additions, modifications, substitutions anddeletions not specifically described may be made without departing fromthe spirit and scope of the invention as defined in the appended claims.

What is claimed is:
 1. A method of collecting a bodily fluid sample froman incision in the skin comprising: pressing against the skin astimulator sleeve of a bodily fluid sampling device around the incisionto express the bodily fluid sample; and moving a capillary tube of thebodily fluid sampling device towards the incision by moving thecapillary tube relative to the stimulator sleeve while the sleeveremains in contact with the skin.
 2. The method of claim 1, furthercomprising forming the incision in the skin with a needle of the bodilyfluid sampling device.
 3. The method of claim 1, further comprisingforming the incision with the bodily fluid sampling device before saidmoving.
 4. The method of claim 3, further comprising drawing the bodilyfluid from the incision into the capillary tube.
 5. The method of claim4, further comprising transferring the bodily fluid onto a test striplocated at one end of the capillary tube.
 6. The method of claim 5,further comprising analyzing the bodily fluid on the test strip.
 7. Themethod of claim 1, further comprising drawing the bodily fluid from theincision into the capillary tube.
 8. The method of claim 7, furthercomprising transferring the bodily fluid from the capillary tube onto atest strip.
 9. The method of claim 8, further comprising analyzing thebodily fluid on the test strip.
 10. A method of collecting a sample ofbodily fluid from an incision in the skin, comprising: pressing againstthe skin a stimulator sleeve of a bodily fluid sampling device aroundthe incision to express at least a drop of the bodily fluid; and movinga means for collecting the bodily fluid in the bodily fluid samplingdevice towards the drop by moving the means for collecting the bodilyfluid relative to the stimulator sleeve while the sleeve remains incontact with the skin.
 11. The method of claim 10, wherein: the meansfor collecting the bodily fluid includes a capillary tube with an end;and said moving includes extending the end of the capillary tube towardsthe drop.
 12. The method of claim 10, wherein: the bodily fluid samplingdevice includes an inner sleeve having a slot; the stimulator sleeve isslidable relative to the inner sleeve; the means for collecting thebodily fluid includes a test strip received in the slot of the innersleeve; and said moving includes sliding the inner sleeve relative tothe stimulator sleeve to contact the test strip with the drop.
 13. Themethod of claim 10, further comprising forming the incision with thebodily fluid sampling device before said moving.